This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.
- Clinical Study Risk Management During The COVID-19 Pandemic
- Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions
- Stand By To Stand By: Organizational Contingency Planning
- COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain
- EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications
- Sign The “50 By 25” Declaration Of Drug Independence
- What Pharma Can Learn From A Parent Turned Patient Advocate
Clinical Study Conduct During The COVID-19 Pandemic — Challenges & Solutions
Life science companies across the world are scrambling to mitigate the impacts of COVID-19 on their clinical studies and business operations, and there are no clear-cut answers at this time, nor a one-size-fits-all solution. But what we do know is that we are all in this together and that this is another challenge that the biotech industry was built for.
Stand By To Stand By: Organizational Contingency Planning
The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.
COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain
During crises like this pandemic, bottlenecks in drug distribution and sample testing can be improved through automation, artificial intelligence, and robotics. This article provides an overview of the medical drone industry, with a particular emphasis on its adoption by the pharmaceutical sector to solve logistical problems in healthcare during times of heightened need.
EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications
While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.
What Pharma Can Learn From A Parent Turned Patient Advocate
I am humbled and honored to introduce you to Andrew McFadyen — founder of the Isaac Foundation. Andrew is a husband, a father, and an advocate who tirelessly works to advance actionable dialogue around access, care, and policy for patients with rare diseases. Recently, I had the opportunity to chat with Andrew about the unique challenges that patients and their families face when dealing with serious illness and how we may better serve their needs.
Implementing Data Quality By Design For Improved Data Integrity
We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.
Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies
One of the most frequent statements made in the biopharmaceutical industry is the need to “control a product’s critical quality attributes (CQAs) by controlling the process’ critical process parameters (CPPs).” While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.
Which Biosimilar Companies Will Thrive In 2025?
Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.
PHARMA OUTSOURCING WHITE PAPERS
Small Molecule Impurities: A Control System Design Challenge For ADCs
Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise.
Utilizing External Collaboration To Accelerate Vaccine Development
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.
Can You Afford Not To Outsource Buffer Preparation?
The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.
Developing A Scalable Process For Adenovirus Manufacturing
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Digital Manufacturing Of Biologics
In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities.
More Efficient Bispecific Antibody Purification With Fewer Steps
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma
COVID-19 AND YOUR SUPPLY CHAINS: ANALYSIS AND ADVICE FROM OUTSOURCED PHARMA
More Content Collections
The coronavirus pandemic has tossed together your drug development and manufacturing supply chains with a worldwide health and health-care challenge, national security concerns, and international and domestic politics. Outsourced Pharma Chief Editor Louis Garguilo has covered this convergence from the very beginning of the outbreak. This collection of his editorials and podcast will help you to think through your outsourcing strategy in the face of the outbreak of CORVID-19, and offers some keen analysis and best practices. He suggests biotech and pharma companies take this moment in time to deeply reconsider geographic and other supply-chain risks to enhance decisions for maintaining the most reliable source of drugs and vaccines, and to openly ask and answer difficult questions. Download the eBook now.
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Implementing an Effective CAPA System
April 10, 2020
Writing Excellent SOPs
April 10, 2020
Medical Device Recalls – Keys To Implementing A Successful Approach
April 14 - 14, 2020
1pm-2:30pm EST, Online Training Duration: 90 Minutes
Price: $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response
April 15 - 15, 2020
1pm-2:30pm EDT, Online Training Price: $299 - Includes Bonus Handouts!
Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities
April 16 - 16, 2020
1pm-2:30pm EDT, Online Training Duration: 90-Minutes
Price: $199 - Includes Bonus Handouts!